Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

As a regulatory affairs professional for a specific project team in Japan, you will actively contribute to the development and implementation of regulatory strategies and negotiate with relevant regulatory authorities as needed. You will manage the creation of submission documents for new drug approvals, including Japanese lifecycle management.

Responsibilities

• Actively contribute to the development and implementation of regulatory strategies for assigned projects and programs at all stages of development (pre-Phase I to post-marketing), based on a thorough understanding of regulatory requirements.
• Coordinate regulatory authority consultations and submissions for assigned projects or programs.
• Arrange and prepare meetings with Japanese regulatory authorities for assigned projects.
• Identify and assess regulatory risks for assigned projects or programs.
• Deepen understanding of regulatory affairs and advise project teams.

Requirements

• BA/BS degree or equivalent; Life/Health Sciences preferred.
• 5+ years of experience in biotechnology or pharmaceuticals.
• 4-6 years of regulatory affairs experience or equivalent experience/education.
• Deep understanding of regulations and guidelines.
• Clinical research and drug development experience is desirable.

Experience Level

• Management

Education Level

• BA/BS degree or equivalent; Life/Health Sciences preferred.

About the Company

• We are a global team with a commitment to excellence, and a pioneering spirit.
• As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.
• Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.
• Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.
• Caring Deeply. Achieving Excellence. Changing Lives.
• At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
• We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
• We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change.

Equal Opportunity

• All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
• Biogen is an E-Verify Employer in the United States.